Quality Engineer II

About the role

We are looking for a Quality Engineer II to apply quality engineering tools and techniques across product development, transfers, and supplier management within our medical device portfolio. The role ensures compliance, drives continuous improvement, and supports risk‑based decision making.

Key responsibilities

• Apply quality engineering tools during product development, transfers, design activities, changes and supplier management.
• Develop, validate and transfer test methods for new and existing products and processes.
• Lead problem‑solving sessions and coordinate project phases, including planning and scheduling.
• Create Quality Plans covering specifications, qualification, supplier capability, design validation and reliability strategies.
• Support Global Change Control, CAPA, complaint handling and process mapping in line with Convatec’s validation policies.
• Perform risk management activities for new products, transfers and development initiatives.
• Drive continuous improvement of existing products, processes and the Quality Management System.

Required profile

• Minimum 2 years experience in a similar quality engineering role within the medical device industry.
• Experience with process validation (IQ, OQ, PQ), risk management and technical/regulatory projects.
• Strong communication, time‑management and teamwork skills.
• Intermediate to advanced English proficiency.

Required skills

• Microsoft Project
• Gantt Charts
• OnePager
• Minitab
• Process validation (IQ, OQ, PQ)
• Risk management